Drugs / Daratumumab and hyaluronidase-fihj
Daratumumab and hyaluronidase-fihj
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed indolent plasma cell myeloma 1 milestone | |||||
| Filed | US (FDA) | DARZALEX FASPRO | indolent plasma cell myeloma | 2024-01-30 | “the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for DARZALEXFASPRO®” jnj.com ↗ |
| Filed primary plasmacytoma of the bone 1 milestone | |||||
| Filed | US (FDA) | DARZALEXFASPRO | primary plasmacytoma of the bone | 2024-09-30 | “for approval of a new indication for DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone” jnj.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05300451 | Mar 2022 → Aug 2026 overdue | — | Barry A. Boilson | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 49
| Date | Issuer | Release |
|---|---|---|
| 2026-09-09 | Janssen Research & Development, LLC | Results Johnson & Johnson presents new data at IMS 2026 highlighting its industry-leading multiple myeloma portfolio, with the goal of advancing the potential for cure jnj.com ↗
New analyses from the Phase 3MajesTEC-3study further evaluates overall survival, progression and non-relapse mortality with TECVAYLI®(teclistamab-cqyv) in combination with DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) |
| 2026-06-13 | Janssen Research & Development, LLC | Results New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma jnj.com ↗
Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months.1 |
| 2026-04-29 | Janssen Research & Development, LLC | Results Johnson & Johnson ushers in the next wave of innovation in cancer care with more than 20 clinical and real-world studies at ASCO 2026 jnj.com ↗
Subgroup analysis from the Phase 3 PERSEUS study evaluating the benefit ofDARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) in transplant-eligible patients with high- and standard-risk multiple myeloma (Oral Abstract #7505) |
| 2026-04-29 | Janssen Research & Development, LLC | Results Johnson & Johnson ushers in the next wave of innovation in cancer care with more than 20 clinical and real-world studies at ASCO 2026 jnj.com ↗
Final subgroup analysis from the Phase 3 CEPHEUS study evaluating DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma (Rapid Oral Abstract #7513) |
| 2026-03-05 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line jnj.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI®(teclistamab-cqyv) plus DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) |
| 2026-01-27 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible jnj.com ↗ |
| 2026-01-27 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible jnj.com ↗
DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible |
| 2025-12-15 | Janssen Research & Development, LLC | Regulatory TECVAYLI® plus DARZALEX FASPRO® combination selected for Commissioner’s National Priority Voucher Pilot program jnj.com ↗ |
| 2025-12-09 | Janssen Research & Development, LLC | Results Unprecedented results from the Phase 3 MajesTEC-3 study support TECVAYLI® plus DARZALEX FASPRO® as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma jnj.com ↗
Results show an 83% reduction in the risk of disease progression or death compared to standard regimens at nearly three-years follow-up (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001). |
| 2025-11-06 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® is the first and only treatment approved by the U.S. FDA for patients with high-risk smoldering multiple myeloma jnj.com ↗
Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA) approved DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). |
| 2025-10-16 | Janssen Research & Development, LLC | Results TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care jnj.com ↗
The secondary endpoint of overall survival (OS) was also statistically significant at this first interim analysis. |
| 2025-09-19 | Janssen Research & Development, LLC | Results TECVAYLI® and DARZALEX FASPRO® treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma jnj.com ↗
Johnson & Johnson (NYSE:JNJ) today today announced an investigational regimen of TECVAYLI®(teclistamab-cqyv) and DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) showed meaningful clinical efficacy in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM). |
| 2025-09-19 | Janssen Research & Development, LLC | Results TECVAYLI® plus DARZALEX FASPRO® treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma jnj.com ↗
Patients receiving the immune-based combination as the first treatment after diagnosis achieved a 100 percent overall response rate. |
| 2025-06-03 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity jnj.com ↗ |
| 2025-05-20 | Janssen Research & Development, LLC | Regulatory U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma jnj.com ↗
The vote highlights a pivotal moment in the care of patients most likely to develop active multiple myeloma (MM), potentially altering the course of disease and treatment. |
| 2024-12-08 | Janssen Research & Development, LLC | Results TECVAYLI® (teclistamab-cqyv) demonstrates potential as frontline combination therapy for patients with newly diagnosed multiple myeloma jnj.com ↗
Forty-nine patients with transplant-eligible NDMM were treated with TECVAYLI®in combination with DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone (Tec-DRd) or DARZALEXFASPRO®, bortezomib, lenalidomide and dexamethasone (Tec-DVRd) as induction therapy in the MajesTEC-5 study.1 |
| 2024-12-08 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smoldering multiple myeloma jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced data from the Phase 3 AQUILA study showing that DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) significantly delayed progression from high-risk smoldering multiple myeloma (SMM) to active multiple myeloma (MM) and extended overall survival compared to the current standard of care of active monitoring. |
| 2024-12-08 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimens demonstrate improved rates of minimal residual disease (MRD) negativity and progression-free survival in patients with newly diagnosed multiple myeloma jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced data highlighting that DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj)-based regimens improve overall and sustained minimal residual disease (MRD) negativity rates and progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status. |
| 2024-11-08 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO® / DARZALEX® as subcutaneous monotherapy for high-risk smoldering multiple myeloma jnj.com ↗
Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of a new indication for DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX®subcutaneous (SC) formulation in the European Union (EU). |
| 2024-10-02 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned jnj.com ↗ |
| 2024-09-27 | Janssen Research & Development, LLC | Results TALVEY® (talquetamab-tgvs) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based combination shows deep and durable responses in patients with relapsed or refractory multiple myeloma jnj.com ↗
The Q2W arm (n=59) achieved 76 percent ORR, with 56 percent achieving CR or better. |
| 2024-09-27 | Janssen Research & Development, LLC | Results DARZALEX FASPRO®-based quadruplet regimen significantly improves minimal residual disease negativity for newly diagnosed multiple myeloma patients for whom transplant is not planned jnj.com ↗
Results show that treatment with D-VRd resulted in deeper responses, including MRD-negativity, compared with VRd. |
| 2024-09-27 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab)-based maintenance regimens show clinically meaningful deep and durable responses in transplant-eligible patients with newly diagnosed multiple myeloma jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced data from three studies highlighting clinical efficacy of DARZALEX®(daratumumab) and DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) in maintenance regimens. |
| 2024-07-30 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible jnj.com ↗ |
| 2024-06-03 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab)-based regimens significantly improve clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma jnj.com ↗
The rates of deep and sustained MRD negativity were associated with improved progression-free survival (PFS) with DARZALEXFASPRO®-based quadruplet induction, consolidation and doublet maintenance regimen in these patients versus VRd. |
| 2024-06-03 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab)-based regimens significantly improve clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma jnj.com ↗ |
| 2024-05-23 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗
Daratumumab plus bortezomib/lenalidomide/dexamethasone in transplant-eligible patients with NDMM: analysis of MRD in the PERSEUS trial |
| 2024-01-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma jnj.com ↗ |
| 2024-01-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of DARZALEX FASPRO based regimen for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma jnj.com ↗ |
| 2023-12-12 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma jnj.com ↗
Johnson & Johnson announced today the first data from the Phase 3 PERSEUS study highlighting significant clinical improvement with a DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj)-based quadruplet induction, consolidation regimen and doublet maintenance regimen in the treatment of transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM). |
| 2023-12-12 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma jnj.com ↗ |
| 2023-06-03 | Janssen Research & Development, LLC | Results Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Additional long-term data from the TRiMM-2 study in patients receiving talquetamab and DARZALEX FASPRO® combination biweekly regimen showed an overall response rate of more than 80 percent |
| 2022-12-10 | Janssen Research & Development, LLC | Results Janssen Presents First Data from MajesTEC-2 Trial of TECVAYLI™ (teclistamab-cqyv) in Combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and Lenalidomide in Relapsed or Refractory Multiple Myeloma jnj.com ↗
According to the results, the immune-based triplet therapy regimen had a manageable safety profile with no unexpected safety signals observed. |
| 2022-06-10 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
The Phase 1b TRiMM-2 study (NCT04108195) evaluated talquetamab in combination with DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj), the CD38-directed monoclonal antibody approved to be given subcutaneously for the treatment of patients with multiple myeloma. |
| 2022-06-10 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Results from the study show heavily pretreated patients with multiple myeloma treated with the combination, including talquetamab at the recommended subcutaneous Phase 2 dose (RP2D) administered weekly (QW) or every two weeks (Q2W), achieved high rates of responses, including for patients refractory to anti-CD38 treatment. |
| 2022-06-05 | Janssen Research & Development, LLC | Results Updated Data for Janssen’s Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
Evaluable patients achieved an ORR of 76.5 percent at a median follow-up of 8.6 months (0.3–19.6). |
| 2021-12-11 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Results suggest that the combination is tolerable in patients with relapsed or refractory multiple myeloma who had received a median of six prior lines of therapy (range 2-18), with a safety profile comparable to each agent as a monotherapy at each of three doses evaluated in the study. |
| 2021-12-01 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves DARZALEX FASPRO® (daratumumab and hyaluronidasefihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse jnj.com ↗ |
| 2021-07-12 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse jnj.com ↗
DARZALEX FASPRO® is now the first and only subcutaneous anti-CD38 monoclonal antibody approved in combination with pomalidomide and dexamethasone |
| 2021-05-26 | Janssen Research & Development, LLC | Results Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEXFASPRO®in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003). |
| 2021-05-26 | Janssen Research & Development, LLC | Results Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO® in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003). |
| 2021-01-15 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
DARZALEXFASPRO®is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterioration of vital organs, most notably the heart, kidneys and liver. |
| 2021-01-15 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterioration of vital organs, most notably the heart, kidneys and liver. |
| 2020-12-07 | Janssen Research & Development, LLC | Results Data from the ANDROMEDA Study Show Hematologic Response for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
Data from the ANDROMEDA Study Show Hematologic Response for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Newly Diagnosed Light Chain (AL) Amyloidosis |
| 2020-12-04 | Janssen Research & Development, LLC | Results Data from the APOLLO Study Show Clinically Meaningful Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Regimen After First or Subsequent Relapse in Multiple Myeloma jnj.com ↗
The APOLLO study represents the ninth positive Phase 3 study for daratumumab. |
| 2020-11-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj)/ DARZALEX® (daratumumab) Subcutaneous (SC) Formulation in Combination With Pomalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma jnj.com ↗
The applications seek approval of the combination of DARZALEX FASPRO™/DARZALEX® SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. |
| 2020-09-10 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application Seeking U.S. FDA Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Light Chain (AL) Amyloidosis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) |
| 2020-06-04 | Janssen Research & Development, LLC | Regulatory European Commission Grants Marketing Authorisation for DARZALEX®▼(daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM). |
| 2020-05-01 | Janssen Research & Development, LLC | Regulatory U.S. Food and Drug Administration Approves DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma jnj.com ↗ |
All press releases naming this drug 58 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Daratumumab and hyaluronidase-fihj | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05300451 ↗ |
| Modality | Monoclonal antibody | “Daratumumab is an IgG1k, CD38-targeting monoclonal antibody” NCT05300451 ↗ |